A Randomized Trial Comparing Radiological Tubal Blockage Versus Laparoscopic Salpingectomy in Infertile Women With Hydrosalpinx During in Vitro Fertilization Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- live birth rate
研究概览
简要总结
Hydrosalpinx (HX) has a detrimental effect on the rates of implantation, pregnancy, live delivery, and early pregnancy loss during in vitro fertilization (IVF). The effectiveness of radiological tubal blockage has not been compared with the standard treatment of laparoscopic salpingectomy in randomized trials. The investigators aim in this randomized trial to compare the live birth rate of radiological tubal blockage versus laparoscopic salpingectomy in infertility women with HX prior to frozen-thawed embryo transfer (FET). Eligible women will be recruited and randomized into one of the following two groups: (1) the radiological tubal blockage group and (2) the laparoscopic salpingectomy group. The primary outcome is the live birth rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20-43 years at the time of IVF/ICSI treatment
- •Unilateral or bilateral HX visible on pelvic ultrasound or hysterosalpingogram
- •At least one frozen embryo or blastocyst available for transfer
排除标准
- •A history of pelvic inflammatory disease within 6 months
- •HX that were already blocked proximally on hysterosalpingogram
- •Frozen pelvis from previous laparoscopy
- •Women with fibroids interfering with radiological tubal blockage
- •Undergoing preimplantation genetic testing
研究组 & 干预措施
the radiological tubal blockage group
干预措施: radiological tubal blockage (Procedure)
the laparoscopic salpingectomy group
干预措施: laparoscopic salpingectomy (Procedure)
结局指标
主要结局
live birth rate
时间窗: a live birth after 22 weeks gestation, through study completion, an average of 1 year
the rate of live births per cycle
次要结局
- ectopic pregnancy(ectopic pregnancy during first trimester, up to 12 weeks)
- birth weight(a live birth after 22 weeks gestation, through study completion, an average of 1 year)
- implantation rate(number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks)
- multiple pregnancy(multiple pregnancy beyond gestation 12 weeks up to 12 weeks)
- clinical pregnancy rate(presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks)
- positive hCG level(A blood hCG test is performed 14 days after the FET, up to 14 days)
- ongoing pregnancy rate(iable pregnancy beyond gestation 12 weeks, up to 12 weeks)
- miscarriage rate(a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks)